What is NDC 80425-0264?

80425-0264 is the product NDC for Epinephrine, Epinephrine .3 mg/.3mL injection, listed with the FDA by Advanced Rx Pharmacy of Tennessee, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Advanced Rx Pharmacy of Tennessee, LLC, NDC labeler code 80425. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Epinephrine?

74 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Yes: J0171, Injection, adrenalin, epinephrine, 0.1 mg.

Epinephrine NDC 80425-0264 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)80425-0264Labeler and product segments. Claims need a package NDC.

Product NDC at billing width80425-0264Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
80425-0264-1	80425026401	2 CASE in 1 CARTON (80425-0264-1) / 1 SYRINGE in 1 CASE / .3 mL in 1 SYRINGEMarketed from Feb 16, 2023

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): Epinephrine
Generic name (nonproprietary): epinephrine
Active ingredients: Epinephrine — .3 mg/.3mL
Dosage form: Injection
Route: Subcutaneous
Labeler: Advanced Rx Pharmacy of Tennessee, LLCNDC labeler code 80425
Product type: Prescription drug
Marketing category: NDA authorized genericApplication NDA 020800
Marketing start: Feb 16, 2023
Listing expires: Dec 31, 2026
Other FDA classes: Adrenergic alpha-Agonists (Mechanism)Adrenergic beta-Agonists (Mechanism)Catecholamines (Chemical structure)
Identifiers: Product ID 80425-0264_2a9b7c00-1682-4da0-e063-6394a90a926dSPL ID 2a9b7c00-1682-4da0-e063-6394a90a926dSPL set ID f4d7aca4-0acd-74c2-e053-2995a90a9d94RxCUI 1870230UNII YKH834O4BH
Pharmacologic class: Catecholamine; alpha-Adrenergic Agonist; beta-Adrenergic Agonist

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeMed-Code curated

J0171 — Injection, adrenalin, epinephrine, 0.1 mg

Billing unit: 0.1 mg. Units on the claim = dose given ÷ 0.1 mg.

Applies when epinephrine is administered in a clinical setting. Auto-injectors dispensed to patients are billed by NDC through a pharmacy benefit.

Administration

Drug administration (CPT 96360–96549)

When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.

How CPT relates to drug billing

NDC on a medical claim

N480425026401 followed by a unit qualifier and the quantity

Package 80425-0264-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective Dec 31, 2024.

Indications (excerpt from the label)

1. Indications and Usage Epinephrine injection is indicated in the emergency treatment of allergic reactions (Type I) including anaphylaxis to stinging insects (e.g., order Hymenoptera, which includes bees, wasps, hornets, yellow jackets and fire ants), and biting insects (e.g., triatoma, mosquitoes), allergen immunotherapy, foods, drugs, diagnostic testing substances (e.g., radiocontrast media), and other allergens, as well as idiopathic anaphylaxis or exercise-induced anaphylaxis. Epinephrine injection is intended for immediate administration in patients who are determined to be at increased risk for anaphylaxis, including individuals with a history of anaphylactic reactions. Anaphylactic …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 80425-0264

What is NDC 80425-0264?: 80425-0264 is the product NDC for Epinephrine, Epinephrine .3 mg/.3mL injection, listed with the FDA by Advanced Rx Pharmacy of Tennessee, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Epinephrine.
What is the active ingredient?: Epinephrine.
Who is the labeler?: Advanced Rx Pharmacy of Tennessee, LLC, NDC labeler code 80425. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Epinephrine?: 74 other product NDCs are listed under this name. See all Epinephrine NDCs.
Is there a related HCPCS / J-code?: Yes: J0171, Injection, adrenalin, epinephrine, 0.1 mg. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Epinephrine NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
epinephrine	Epinephrine 1 mg/mL	InjectionIntramuscular, Intravenous, Subcutaneous	Gland Pharma Limited	68083-699	68083-0699-1068083-0699-25
Epinephrine	Epinephrine 1 mg/mL	InjectionIntramuscular, Intravenous, Subcutaneous	Hikma Pharmaceuticals USA Inc.	0143-9476	00143-9476-25
Epinephrine	Epinephrine 1 mg/mL	InjectionIntramuscular, Intravenous, Subcutaneous	HF Acquisition Co LLC, DBA HealthFirst	51662-1708	51662-1708-03
epinephrine	Epinephrine 1 mg/mL	Injection, Solution, ConcentrateIntramuscular, Intravenous, Subcutaneous	Baxter Healthcare Corporation	43066-801	43066-0801-02
epinephrine	Epinephrine 1 mg/mL	Injection, Solution, ConcentrateIntramuscular, Intravenous, Subcutaneous	Baxter Healthcare Corporation	43066-803	43066-0803-25
epinephrine	Epinephrine bitartrate 16 ug/mL	Injection, SolutionIntravenous	Baxter Healthcare Corporation	0338-0006	00338-0006-20
epinephrine	Epinephrine .15 mg/.15mL	InjectionSubcutaneous	REMEDYREPACK INC.	70518-4573	70518-4573-00
epinephrine	Epinephrine 1 mg/mL	InjectionIntramuscular, Intravenous, Subcutaneous	GLENMARK PHARMACEUTICALS INC., USA	68462-761	68462-0761-30
Epinephrine	Epinephrine 1 mg/mL	InjectionIntramuscular, Intravenous, Subcutaneous	Amneal Pharmaceuticals Private Limited	80830-1659	80830-1659-02
epinephrine	Epinephrine 1 mg/mL	InjectionIntramuscular, Intravenous, Subcutaneous	Amneal Pharmaceuticals LLC	70121-1660	70121-1660-02

All 75 Epinephrine NDCs

Other NDCs under NDA 020800

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 020800
Product	Strength	Form · route	Labeler	Product NDC
Epinephrine	Epinephrine .15 mg/.15mL	InjectionSubcutaneous	HF Acquisition Co LLC, DBA HealthFirst	51662-1222
Epinephrine	Epinephrine .3 mg/.3mL	InjectionSubcutaneous	HF Acquisition Co LLC, DBA HealthFirst	51662-1223
epinephrine	Epinephrine .3 mg/.3mL	InjectionSubcutaneous	Asclemed USA, Inc.	76420-834
epinephrine	Epinephrine .15 mg/.15mL	InjectionSubcutaneous	Asclemed USA, Inc.	76420-835
epinephrine	Epinephrine .15 mg/.15mL	InjectionSubcutaneous	REMEDYREPACK INC.	70518-4573
Epinephrine Pediatricsepinephrine 0.15 pediatrics	Epinephrine .15 mg/.15mL	InjectionSubcutaneous	Sina Health Inc	70385-2038
epinephrine	Epinephrine .3 mg/.3mL	InjectionSubcutaneous	Amneal Pharmaceuticals of New York LLC	0115-1694
epinephrine	Epinephrine .15 mg/.15mL	InjectionSubcutaneous	Amneal Pharmaceuticals of New York LLC	0115-1695
Epinephrine 0.3 Adults	Epinephrine .3 mg/.3mL	InjectionSubcutaneous	Sina Health Inc	70385-2022
epinephrine	Epinephrine .3 mg/.3mL	InjectionSubcutaneous	REMEDYREPACK INC.	70518-2048
epinephrine	Epinephrine .3 mg/.3mL	InjectionSubcutaneous	A-S Medication Solutions	50090-3155
epinephrine	Epinephrine .3 mg/.3mL	InjectionSubcutaneous	Sportpharm LLC	85766-061
epinephrine	Epinephrine .3 mg/.3mL	InjectionSubcutaneous	ASCLEMED USA INC.	76420-467